The Voice of the Patient: Female Sexual Dysfunction

The Voice of the Patient

A series of reports from the U.S. Food and Drug Administration's (FDA's) Patient-Focused Drug Development Initiative

Female Sexual Dysfunction Public Meeting: October 27, 2014

Report Date: June 2015

Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration (FDA)

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Table of Contents Introduction .......................................................................................................................... 3

Meeting overview ..................................................................................................................................... 4 Report overview and key themes ............................................................................................................. 5 Topic 1: The Effects of Female Sexual Dysfunction that Matter Most to Patients .................... 6 Perspectives on most significant symptoms............................................................................................. 7 Overall impact of female sexual dysfunction on daily life ........................................................................ 9 Topic 2: Patient Perspectives on Treatments for Female Sexual Dysfunction ........................ 10 Experimental or off-label prescription therapies ................................................................................... 11 Non-prescription or non-drug therapies ................................................................................................ 12 Perspectives on an ideal treatment for female sexual dysfunction ....................................................... 12 Other considerations on drug development for female sexual dysfunction.......................................... 13 Summary of Comments Submitted to the Public Docket ...................................................... 14 Conclusion........................................................................................................................... 17

Appendix 1: Meeting Agenda and Discussion Questions....................................................... 18 Appendix 2: FDA and Patient Panel Participants................................................................... 20 Appendix 3: Meeting Polling Questions................................................................................ 21 Appendix 4: Incorporating Patient Input into a Benefit-Risk Assessment Framework for Female Sexual Interest/Arousal Disorder (FSIAD)................................................................. 23

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Introduction

On October 27, 2014, FDA held a public meeting to hear perspectives from women with female sexual dysfunction (FSD) on their condition and on currently available therapies. FDA focused the meeting on the sexual interest and arousal symptoms associated with FSD because disorders of sexual interest and arousal are reported to be the most common forms of FSD and there are no FDA-approved therapies for treating these symptoms. FDA conducted the meeting as part of the agency's Patient-Focused Drug Development initiative, an FDA commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) to more systematically gather patients' perspectives on their condition and available therapies to treat their condition. As part of this commitment, FDA is holding at least 20 public meetings between Fiscal Years 2013 - 2017, each focused on a specific disease area. More information on this initiative can be found at .

The October 27 patient-focused meeting was part of a two-day FDA workshop to explore important issues with respect to the development of safe and effective drug therapies for FSD. On October 28, 2014, FDA held a scientific meeting with experts to discuss several scientific challenges associated with drug development, including diagnostic criteria, endpoints, and patient-reported outcome instruments. This report focuses on the October 27 patient-focused meeting. The archived webcast and transcript for the October 28 meeting are available on the meeting webpage.

Overview of female sexual dysfunction

Female sexual dysfunction (FSD) is a complex and multi-faceted disorder that has a wide spectrum of symptoms and severity. The term FSD covers a heterogeneous collection of conditions that have previously been classified into four different disorders: hypoactive sexual desire disorder (HSDD) characterized by a reduced or absent interest in sexual activity, female sexual arousal disorder (FSAD) characterized by an inability to attain or maintain sexual excitement, female orgasmic disorder characterized by the difficulty to attain orgasm despite sufficient arousal, and sexual pain disorder characterized by pain during sexual intercourse.

In May 2013, HSDD and FSAD were combined into a single diagnosis of female sexual interest/arousal disorder (FSIAD) in the Fifth Edition of the Diagnostic and Statistical Manual (DSM-5).1 For a woman to be diagnosed with FSIAD, her symptoms of reduced sexual interest/arousal must have been present for at least six months, and must be severe enough to be a source of personal distress. FSIAD can be lifelong or acquired, range from mild to severe, and may be generalized or situational. There is currently no precise measure of the prevalence of FSIAD. However, one survey of U.S. women found that 12% of women reported experiencing personally distressing sexual problems.2

Pharmaceutical treatments for FSD are limited. There are FDA-approved products for treating moderate to severe pain during sexual intercourse related to vulvar and vaginal atrophy associated with menopause; however there are no drugs approved by FDA to specifically treat FSIAD, HSDD, or FSAD. Other prescription products are used off-label by patients, including sildenafil, testosterone or estrogen

1 American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC 2 Shifren et al. Sexual problems and distress in United States women ? prevalence and correlates. Obstet Gynecol. 2008;112:970-8

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hormonal therapies, and antidepressants. However, these products have either not demonstrated effectiveness for FSD or have potential safety issues if taken long-term. Non-drug therapies include lubricants, devices, behavioral or couples therapy, and lifestyle modifications.

Drug development for FSIAD is complicated due to many factors, such as the limited understanding of the underlying medical condition that may be responsible for the dysfunction, challenges in diagnosing the condition, difficulty in identifying outcomes that are both meaningful to patients and are measurable, and the complexity associated with designing trials that can reliably assess the drug's efficacy and safety.

Meeting overview

This meeting gave FDA the opportunity to hear directly from patients and patient representatives (including partners, healthcare providers, and patient advocates) about their experiences with female sexual dysfunction and its treatments. Discussion focused on two key topics: (1) the effects of female sexual dysfunction that matter most to patients and (2) patients' perspectives on treatments for female sexual dysfunction. The discussion questions (Appendix 1) were published in a Federal Register notice that announced the meeting.

For each topic, a panel of patients with FSD (Appendix 2) shared comments to begin the dialogue. Panel comments were followed by a facilitated discussion inviting comments from other patients and patient representatives in the audience. An FDA facilitator led the discussion, and a panel of FDA staff (Appendix 2) asked follow-up questions. Participants who joined the meeting via live webcast (referred to in this report as web participants) were also able to contribute comments. In addition, in-person and web participants were periodically invited to respond to polling questions (Appendix 3), which provided a sense of the demographic makeup of participants and how many participants shared a particular perspective on a given topic.3

Approximately 50 patients with FSD or patient representatives attended the meeting in-person, and approximately 30 patients or patient representatives provided input through the live webcast. According to their responses to the polling questions, in-person participants represented an even distribution of age (from below 30 to above 70), whereas the majority of web participants were less than 50 years of age. About one-half of in-person participants and most web participants indicated that they have had symptoms for 10 years or less. Most in-person participants reported that they were diagnosed with a form of FSD by a healthcare provider, while most web participants reported that they were not formally diagnosed. Based on the meeting discussion, it appears that in-person participants in general have received more specific care (e.g., from a specialist on sexual health) than is expected in the patient population and they were more familiar with FSD treatments and other aspects of drug development. Some participants voluntarily disclosed that their travel to the meeting was funded. Although meeting participants may not fully represent the population living with FSD, their input reflected a range of experiences with its symptoms and treatments.

3 The polling questions were intended as a discussion aid only, and not for scientific purposes. Polling results should not be interpreted as being representative of the overall FSD patient population.

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To supplement the input gathered at the meeting, patients and others were encouraged to submit comments on FSD to a public docket,4 which was open until December 29, 2014. A total of 110 comments were submitted to the public docket by patients and other stakeholders, including academicians, healthcare professionals, consumer groups, and women's health advocates.

More information, including the archived webcast and meeting transcript, is available on the meeting website:

Report overview and key themes

This report summarizes the input provided by patients and patient representatives at the meeting or through the webcast. It also includes a summary of comments submitted to the public docket. The report is intended to reflect the content of this meeting and the docket comment submissions as they relate to patient perspectives on FSD symptoms, impacts, and current treatments.5 To the extent possible, the terms used in this summary to describe symptoms, impacts, and treatment experiences reflect the words used by in-person participants, web participants, and docket commenters. The report is not purported to be representative in any way of the views and experiences of the entire FSD patient population or of any specific group of individuals or entities. There may be symptoms, impacts, treatments, or other perspectives on the condition that are not included in the report.

The input from the meeting and docket comments underscores the significant impact that symptoms of FSD can have on women's lives, and the challenges they face in finding safe, effective, and tolerable therapies to manage their condition. It also highlights the range of perspectives on the need for drug therapies for FSIAD. Several key themes emerged from this meeting:

? The women who participated in this meeting conceptualize and experience sexual interest (or desire, as the term most participants used) distinct from sexual arousal. They varied in their experience of reduced or absent interest, reduced or absent arousal, or both. Some, but not all, also experience other aspects of FSD, including pain, dryness, or inability to orgasm, which they believe contributes to their lack of desire. Participants appeared to believe that their most significant symptoms of their condition are multi-faceted and broader than the six specific sexual symptoms of FSIAD outlined in the DSM-5.

? Many participants and docket commenters described a distinct transition from a prior fulfilling sex life to a total loss of interest or arousal. Regardless of their varying beliefs about the causes or triggers of their interest or arousal symptoms, participants stressed the significant distress it causes daily. They described never initiating sexual contact, the measures they take to avoid intimacy, and persistent anxiety. They further described the profound impact their FSD has on their relationships, their self-identity, and their emotional well-being.

4 A docket is a repository through which the public can submit electronic and written comments on specific topics to U.S. federal agencies such as FDA. More information can be found at . 5 The public was also able to provide input at the October 27 meeting on other issues related to drug development, through an open public comment session. These comments are available through the meeting transcript and archived webcast, but may not be summarized in this report.

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